Success after a long road. A total artificial heart has been marketed in Italy to be implanted there on a patient in order to act as a relay while waiting for a transplant. The biomedical company Carmat, created in 2008, congratulated itself on July 19 for having crossed a “Major step, which opens a new page in the development of the company”.
→ READ. Carmat artificial hearts soon to be marketed in France
This sale rewards the progress made in mastering this device, which had not yet been used outside of clinical studies. Stéphane Piat, CEO of Carmat, sees it “An incredible advance”, a few days after the announcement of the first implantation of his heart in the United States, as part of a clinical study.
The first prototype of a total artificial heart was designed in 2008 by Professor Alain Carpentier with the support of Matra Défense (Airbus Group) and Truffle Capital. But several serious problems arose during the first operations, including the death of the first patient implanted in 2014 following the sudden shutdown of the mechanism. As a result, the National Medicines Safety Agency (ANSM) has suspended trials on several occasions, especially in 2016-2017.
→ READ. February 14, 1986, the first artificial heart implanted in France
Faced with numerous requests for documents and guarantees from the ANSM, the company mentioned “Obstacles to innovation” and hesitated to continue its activity in France. But rumors of a departure for the United States were ultimately denied and an agreement reached for the resumption of testing.
Carmat persevered and obtained, at the end of 2020, the CE marking, sesame for the marketing of its product in Europe, thanks to positive intermediate results of a study showing that three quarters of the patients implanted hadreached six months of survival.
Carmat was also able to count on the support of the public investment bank Bpifrance to the tune of 33 million euros, i.e. ” the most important aid ever given to an SME “. She hopes for further marketing, particularly in France and Germany.
The study launched in the United States also allows, according to Stéphane Piat, to consider a “development in the world’s largest medical devices market “. Monday July 19, the Carmat share gained nearly 12% on the stock market.